The effect of TNF blocking therapy on cardiac function in patients with active rheumatoid arthritis

Completed

Conditions: heart disease
Rheumatoid arthritis
10019280
10003816

Registration Number: NL-OMON44306

Lead Sponsor: Jan van Breemen Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Diagnosis rheumatoid arthritis
Written informed consent
Active disease (DAS28>=3.2) and/or C-reactive protein >10 mg/l and/or Erythrocyte Sedimentation Rate (ESR) > 15 mm/h

Exclusion Criteria

Medical history of cardiac disease (i.e. myocardial infarction, heart failure etc)
Use of TNF blocking therapy 3 months prior to start study

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is diastolic LV dysfunction, defined as follows:<br /><br><br /><br>mild diastolic LV dysfunction (stage Iimpaired relaxation). Characterized by<br /><br>an E/A ratio <1, Em/Am <1, prolonged DT (>240 ms), and IVRT (>110 ms). Em (<8<br /><br>cm/s) is reduced. E/Em is <10.<br /><br><br /><br>Moderate diastolic LV dysfunction (stage II pseudo normalization).<br /><br>Characterized by an E/A ratio >1, Em/Am <1. Em (<8 cm/s) is reduced and E/Em is<br /><br>>10.<br /><br><br /><br>Severe diastolic LV dysfunction (stage III* restrictive filling). This stage is<br /><br>characterized by an overt increased E/A ratio (>2), shortened DT (<150 ms), and<br /><br>IVRT (<60 ms). Em (<8 cm/s) remains at the lowest level. E/Em is >10. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes:<br /><br><br /><br>Systolic LV dysfunction will be defined as an ejection fraction of <50%.<br /><br><br /><br>NT-proBNP, IL-6, troponin-I, sTNFR1, sTNFR2 and TNF-a. High NT-proBNP is<br /><br>defined as 125 pg/ml.<br /><br><br /><br>Conduction times will be defined as abnormal if PQ time <0.12 or >0.20 seconds,<br /><br>QRS duration <0.12 seconds and (corrected) QTc interval <450 milliseconds for<br /><br>men and 460 milliseconds for women. </p><br>